The FDA recalled 60 medical devices last year, and the running total for this year is 56. The good news is that there’s a startup working to make future totals lower.
The startup, named Ketryx, announced the close of a $14 million Series A funding round on Tuesday. The round, which brings the company’s total funding amount to $18 million, was led by Lightspeed Venture Partners.
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Ketryx, which was founded in 2021, is based in Somerville, Massachusetts and Vienna, Austria. It’s on a mission to make medical software quality assurance less error-prone, said CEO Erez Kaminski.
“Humans make mistakes. Computers do not. Traditional quality assurance uses humans to manually check thousands to tens of thousands of different line items before a product can go live. The average length of a 510k document according to the FDA is now over 2,000 pages, and we have customers who have submissions in the realm of 10,000 pages,” he explained.
With numbers this large, just a 0.1% error rate means that 10 errors would be made in a submission with 10,000 line items, Kaminski pointed out.
The infrastructure and processes that medical device makers use for quality assurance “were simply not built” for the complexity of today’s software, he declared. Because of this, device manufacturers lack the tools they need to release and monitor software at scale, especially when it comes to new AI models.
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Traditional quality assurance methods are also time-consuming, with the process taking months or sometimes years for a single device, Kaminski added.
“Now imagine that these companies want to release software monthly instead of annually. Or weekly — in most of the tech industry, it’s done daily today. They now have to go through all of these checks at the same cadence. This simply isn’t possible when documentation and quality checks are done manually,” he said.
To address these issues, Ketryx created a platform — designed around FDA regulations and quality standards — that automates much of the work required from medical device companies’ development and quality teams.
“Ketryx connects with modern development tools like Jira, GitHub, and AWS. As developers work in these preferred tools, Ketryx automatically generates all of the FDA-required documentation directly from these tools and enforces the company’s quality procedures in them as well,” Kaminski explained.
This allows developers to work without having to reference procedures or keep manual records, he pointed out.
Ketryx’s target customers are companies that make medical devices or sell software as medical device (SaMD). Some of the customers listed on the startup’s website include Talkiatry, Beacon Biosignals, Galen Robotics and DocBox.
In Kaminski’s view, Ketryx’s biggest competitors are companies’ internal teams in charge of creating home-grown systems or augmenting general-purpose tools to accommodate regulated software development.
“Similar to the reasons why teams purchase Shopify instead of building their own e-commerce application, Ketryx offers the promise of staying in sync with the market. As FDA regulations and submission requirements change, Ketryx has the scale and purpose to make updates that quickly help teams stay in compliance. So too, as the use of AI/ML progresses and software tools improve, Ketryx will make these rapidly available for use in this regulated environment,” he declared.
Additionally, Ketryx differs from internal solutions because it automatically generates FDA-compliant documentation, as well as automates the enforcement of standard operating procedures, Kaminski said. He also said that his startup is constantly increasing the number of native integrations available on its platform, something that “in-house teams wouldn’t have the resources to complete.”
Photo: marchmeena29, Getty Images
